Acute Myeloblastic Leukemia Core Binding FactorRETRO-CBFNCT05070208
Multicenter Retrospective Observatory of Patients With Acute Myeloid Leukemia to Core Binding Factor
An observational study of Acute Myeloblastic Leukemia Core Binding Factor, run by Acute Leukemia French Association at 26 sites in France.
Trial summary
Acute Core Binding Factor leukemias represent a specific category of acute myeloid leukemias that share prognostic factors, a specific mutational profile, and a favorable response to chemotherapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Myeloblastic Leukemia Core Binding Factor
- What is being tested?
- NOT PROVIDED
- How many people
- 400 participants
- Where
- 26 sitesFrance
- Study dates
- 22 Sep 2021to 5 May 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Core Binding Factor Acute Myeloid Leukemia
Who may be able to join
- Patients over 18 years old
- Diagnosis of acute myeloid leukemia with CBF confirmed by cytogenetics (karyotype and / or FISH): t (8; 21), inv (16) or t (16; 16) and / or molecular biology (RUNX1-RUNX1T1 fusions or CBFB-MYH11)
- Initial management by intensive chemotherapy, hypomethylants or targeted therapies
Who cannot join
- Opposition expressed to research
Trial locations and contacts
26 sites in 1 country.
26 sites in 1 country
France26 sites
Chu Amiens
Amiens
Centre Hospitalier Victor Dupouy
Argenteuil
AP-HP-GHU - Hôpital AVICENNE
Bobigny
CHU de la cote de Nacre
Caen
CH Métropole Savoie
Chambéry
Hôpital MILITAIRE PERCY
Clamart
Centre hospitalier Sud Francilien
Corbeil-Essonnes
Henri Mondor Aphp
Créteil
Dijon Chu
Dijon
Centre Hospitalier de Dunkerque
Dunkirk
Centre Hospitalier de Versailles André Mignot
Le Chesnay
LENS CHR
Lens
CHU
Lille, 59037
Limoges Chu
Limoges
CHU La Conception
Marseille
Centre Antoine Lacassagne
Nice
CHU Nice,Hopital Archet 1
Nice
Hopital Pitié-Salpétrière APHP
Paris
Hôpital Necker - APHP
Paris
Hôpital Saint Louis- APHP
Paris
Saint Antoine
Paris
Centre Hospitalier Lyon Sud
Pierre-Bénite
Centre Hospitalier René Dubos
Pontoise
Centre Hospitalier de Roubaix
Roubaix
Centre Hospitalier de St Quentin
Saint-Quentin
Institut Gustave Roussy
Villejuif
About this study
Acute Core Binding Factor leukemias represent a specific category of acute myeloid leukemias that share prognostic factors, a specific mutational profile, and a favorable response to chemotherapy. Their management now follows the reference pattern from the French trial CBF-2006 closed to inclusions since November 2010. This includes intensive chemotherapy and intensification by allogeneic marrow transplant depending on the residual disease measured by RT qPCR . These leukemias have not been the subject of multicenter clinical trials since that date.
The results of this treatment regimen need to be evaluated. Known prognostic factors such as signaling mutations, clonal interference or residual disease follow-up (MRD) will be analyzed and updated in this recent cohort. The interaction between residual disease and mutational profile will be evaluated on the prognosis. Treatment with gemtuzumab-ozogamycin and first-line allogeneic transplantation will be investigated, depending on prognostic factors including associated mutations and residual disease. The course and early treatment of molecular relapses will be analyzed. The treatment and prognosis of cytological relapses will be described with in particular the role of tyrosine kinase inhibitors and therapeutic intensification.
Read the detailed description
NOT PROVIDED
- Being tested
- NOT PROVIDED
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NOT PROVIDEDOther
NOT PROVIDED
What is being measured
The primary outcome is the main question the study is designed to answer.
Event-free survival (EFS)
Measured: December 2010 to December 2020
Secondary outcomes (8)
- Complete remission rate (CR / CRp)
Measured: December 2010 to December 2020
- Overall survival (OS), relapse free survival (DFS) +/- censored with allogeneic transplant
Measured: December 2010 to December 2020
- Cumulative incidence of relapse (CIR) +/- censored at allograft
Measured: December 2010 to December 2020
- Second complete remission rate, OS, EFS, DFS and CIR post-relapse
Measured: December 2010 to December 2020
-Prognostic impact on OS, CR, EFS, DFS and CIR of recurrent somatic mutations
Measured: December 2010 to December 2020
- Interaction between mutations and MRD on OS, CR, EFS, DFS and CIR
Measured: December 2010 to December 2020
- Cumulative incidence of molecular relapse.
Measured: December 2010 to December 2020
- Prognostic impact on OS, CR, EFS, DFS, CIR and post-relapse survival of using first-line GO and relapsing
Measured: December 2010 to December 2020
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2021
- Study start22 Sep 2021
- Primary completion25 Jan 2024
- Study completion5 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myeloblastic Leukemia Core Binding FactorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Acute Leukemia French Association
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- ITZYKSON Raphael, Dr, Principal investigator, SAINT LOUIS PARIS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05070208
- Sponsor's protocol ID
- RETRO-CBF
- Acronym
- RETRO-CBF
- Status last verified
- Sep 2025
- First submitted
- 27 Sep 2021
- Last updated
- 2 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Retrospective Observatory of Patients With Acute Myeloid Leukemia to Core Binding Factor
- ClinicalTrials.gov ID
- NCT05070208
- Acronym / sponsor ID
- RETRO-CBF / RETRO-CBF
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- Acute Leukemia French AssociationUniversity, hospital or other
- Study start
- 22 Sep 2021 (actual)
- Primary completion
- 25 Jan 2024 (actual)
- Study completion
- 5 May 2024 (actual)
- First posted
- 7 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Acute Core Binding Factor leukemias represent a specific category of acute myeloid leukemias that share prognostic factors, a specific mutational profile, and a favorable response to chemotherapy. Their management now follows the reference pattern from the French trial CBF-2006 closed to inclusions since November 2010. This includes intensive chemotherapy and intensification by allogeneic marrow transplant depending on the residual disease measured by RT qPCR . These leukemias have not been the subject of multicenter clinical trials since that date.
The results of this treatment regimen need to be evaluated. Known prognostic factors such as signaling mutations, clonal interference or residual disease follow-up (MRD) will be analyzed and updated in this recent cohort. The interaction between residual disease and mutational profile will be evaluated on the prognosis. Treatment with gemtuzumab-ozogamycin and first-line allogeneic transplantation will be investigated, depending on prognostic factors including associated mutations and residual disease. The course and early treatment of molecular relapses will be analyzed. The treatment and prognosis of cytological relapses will be described with in particular the role of tyrosine kinase inhibitors and therapeutic intensification.
Detailed description
NOT PROVIDED
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Core Binding Factor Acute Myeloid Leukemia
Key inclusion criteria (3 listed)
- Patients over 18 years old
- Diagnosis of acute myeloid leukemia with CBF confirmed by cytogenetics (karyotype and / or FISH): t (8; 21), inv (16) or t (16; 16) and / or molecular biology (RUNX1-RUNX1T1 fusions or CBFB-MYH11)
- Initial management by intensive chemotherapy, hypomethylants or targeted therapies
Key exclusion criteria (1 listed)
- Opposition expressed to research
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NOT PROVIDEDNOT PROVIDED | Other | – |
Primary outcome
Event-free survival (EFS)
Time frame: December 2010 to December 2020
8 secondary outcomes
- Complete remission rate (CR / CRp)
Time frame: December 2010 to December 2020
- Overall survival (OS), relapse free survival (DFS) +/- censored with allogeneic transplant
Time frame: December 2010 to December 2020
- Cumulative incidence of relapse (CIR) +/- censored at allograft
Time frame: December 2010 to December 2020
- Second complete remission rate, OS, EFS, DFS and CIR post-relapse
Time frame: December 2010 to December 2020
-Prognostic impact on OS, CR, EFS, DFS and CIR of recurrent somatic mutations
Time frame: December 2010 to December 2020
- Interaction between mutations and MRD on OS, CR, EFS, DFS and CIR
Time frame: December 2010 to December 2020
- Cumulative incidence of molecular relapse.
Time frame: December 2010 to December 2020
- Prognostic impact on OS, CR, EFS, DFS, CIR and post-relapse survival of using first-line GO and relapsing
Time frame: December 2010 to December 2020
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2025.
- Individual participant dataSharing planned: No
Related trials for Acute Myeloblastic Leukemia Core Binding Factor
RecruitingPhase 2
Testing the Addition of Venetoclax or Gemtuzumab Ozogamicin (GO) to Usual Treatment Regimen (Cytarabine and Daunorubicin, "7+3") for Core Binding Factor Acute Myeloid Leukemia (CBF-AML) to Improve Response (A MYELOMATCH Treatment Trial)
Core Binding Factor Acute Myeloid Leukemia
RecruitingPhase 2
Fludarabine Phosphate, Cytarabine, Filgrastim-sndz, Gemtuzumab Ozogamicin, and Idarubicin Hydrochloride in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndrome
Acute Myeloid Leukemia With Inv(16)(p13.1q22); CBFB-MYH11, Acute Myeloid Leukemia With t(16;16)(p13.1;q22); CBFB-MYH11
RecruitingObservational study
The Efficacy of Allo-HSCT in ND HR-CBF-AML
Acute Myeloid Leukemia
RecruitingPhase 2
Safety and Efficacy of Avapritinib in Relapsed or Refractory Pediatric CBF-AML With KIT Mutation
AML, Childhood, Relapse/Recurrence
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ITZYKSON Raphael, Dr principal investigator
SAINT LOUIS PARIS
26 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Myeloblastic Leukemia Core Binding Factor, run by Acute Leukemia French Association at 26 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 26 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Event-free survival (EFS) (time frame: December 2010 to December 2020). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2025.